Truvada Lawsuit - Legal Claims for Bone Loss & Kidney Failure

Diagnosing bone loss for a Truvada TDF lawsuit

Personal injury attorney Neil Shouse explains how Truvada and other similar HIV medications cause bone loss and osteoporosis, and how victims can diagnose this bone damage and file a lawsuit. Shouse law group is filing lawsuits against Gilead Sciences, the maker of the TDF-based drug Truvada, for the dangerous side effects that their drug Truvada has caused. Some other drugs that use the same TDF-based formulas, and cause the same health problems are Atripla, Complera, Stribild, and Viread. Patients who have taken any of the above medications, and suffered health problems, can also be part of the lawsuit. Some of the bone loss problems associated with TDF drugs are: 1.) Osteoporosis — where the bone undergoes demineralization and becomes less dense 2.) Osteopenia — a milder form of osteoporosis and 3.) Osteomalacia — when the bone becomes softer. Each of these conditions can lead to an increase in broken bones and other bone injuries, and they are caused by Truvada and other similar medications. Weakening bones can lead to tooth issues, increased bone fractures, and a lack of overall skeletal strength. But to know for sure whether you have one of the above conditions, you most take a DXA test, also known as a DEXA scan. This test analyzes the bone health in patients, and finds symptoms like demineralization, helping to diagnose osteoporosis. DEXA scans are normally covered by health insurance, and are an important first step to possible treatments that can counteract the side effects of Truvada, making bones stronger over time. Furthermore, victims of the dangerous drug Truvada must first take a DEXA scan and get an official diagnosis of osteoporosis or one of the other related diseases, before they can sue the drug maker for a money settlement. More info at https://www.shouselaw.com/torts/truvada/side-effects/bone-loss or call (888) 327-4652 for a free consultation. If you or a loved one has suffered dangerous side effects from Truvada or any other TDF drug, we invite you to contact us at Shouse Law Group. We can provide a free consultation in office or by phone. We have local offices in Los Angeles, the San Fernando Valley, Pasadena, Long Beach, Orange County, Ventura, San Bernardino, Rancho Cucamonga, Riverside, San Diego, Sacramento, Oakland, San Francisco, San Jose and throughout California.


A Truvada lawsuit
 is a claim against the pharmaceutical company Gilead Sciences, Inc. for the dangerous side effects of Truvada.

Truvada is an antiviral medication prescribed to treat and prevent HIV and AIDS. But it has been linked to kidney disease and bone damage. The lawsuits allege that:

  1. Gilead delayed a safer drug for a decade in order to boost profits from Truvada's patent, and
  2. Truvada had a design defect.

Shouse Law Group is a California-based law firm representing victims of Truvada-based drugs. We accept cases from across the United States. We fight to recover money settlements for Truvada victims.

What medications are subject to the litigation?

  • Truvada, Gilead's original TDF (tenofovir disoproxil fumarate) medication. 
  • Atripla, which is used only for HIV treatment, not prevention. Also goes by the name Efavirenz.
  • Complera, which is used only for HIV treatment, not prevention. Also goes by the name Rilpivirine.
  • Stribild, which is used for HIV treatment, not prevention. Also goes by the name Elvitegravir, Cobicistat, and Emtricitabine.
  • Viread, which treats Hepatitis B in addition to HIV. Also goes by the name Tenofovir DF.

Common Injuries from Truvada and similar TDF medications

  • Kidney disease, which is when damage to the kidneys prevents them from filtering blood properly. Anything below a 90 GFR (glomerular filtration rate) is abnormal. Truvada's "poor bioavailability" keeps the body from efficiently absorbing the drugs. This leads to kidney problems. 
  • Kidney failure is kidney disease left untreated. Patients would then need a kidney transplant or dialysis to filter waste from their blood. Kidney failure can be acute or chronic.
  • Fanconi Syndrome, which is when impaired kidney tubule function affects the urine's chemical makeup. This includes abnormal protein levels in the urine, called proteinuria. Fanconi Syndrome can lead to kidney damage and bone loss.
  • Osteopenia, which is weakened bones (including teeth). Left untreated, it could lead to breaks and fractures.
  • Osteoporosis is when bones become brittle and may fracture easily.
  • Osteomalacia occurs when bones break down more quickly than they can re-form.

The current litigation

Presently, we are bringing in the Northern District of California (federal court) as well in various state courts. These state court cases are currently being consolidated into a JCCP. This is short for Judicial Council Coordination Proceeding.

A JCCP is like the state-level version of an MDL (multidistrict litigation). This is where similar lawsuits are consolidated to speed up litigation and a settlement. The Truvada JCCP is called Gilead Tenofovir Cases and Coordinated Actions, JCCP No. 5043.

This JCCP's pretrial motions will be heard in Los Angeles County Superior Court under Judge Kenneth R. Freeman. Jury trials will take place in San Francisco County Superior Court under Judge Andrew Cheng.

In this article, we will discuss:

truvada pills
Truvada, also known as Emtricitabine/tenofovir

1. What is Truvada?

Truvada is a drug that treats and prevents HIV and AIDS. It combines the chemicals emtricitabine and tenofovir disoproxil fumarate (TDF). The drug stops HIV cells from multiplying once in the body.

One of the drugs in Truvada, TDF, has been around since the 1980s. However, its use for HIV had been limited because it could only be taken intravenously. When Gilead Sciences, Inc. bought the rights to sell TDF, they modified it so it could be taken orally, in the form of a pill. That oral medication was approved by the U.S. Food and Drug Administration (FDA) in 2001 under the brand name Viread.1 Truvada was approved by the FDA in 2004.2

2. What are the health risks associated with Truvada?

Truvada has been linked to a number of serious severe side effects, including:

  • Decreased bone density and osteoporosis,3
  • Kidney damage and renal failure,4 and
  • Lactic acidosis.5

2.1. Decreased bone density and osteoporosis

One of the serious side effects of Truvada is a decrease in bone density. This can lead to osteopenia, osteomalacia and osteoporosis. 

Truvada is not a cure for HIV or AIDS. It is rather a treatment for the conditions. Thus it is intended to be taken for prolonged periods of time. This long-term exposure to Truvada and the drug TDF takes a significant toll on a patient's bone density. It significantly increases the risks for:

  • Bone fractures,
  • Broken bones,
  • Osteopenia, and
  • Osteoporosis.

2.2. Kidney damage and renal failure

Truvada was designed to be taken in high doses for such a long time. It is up to the kidneys to expel the drug from a patient's system. Therefore Truvada puts stress on the kidneys as well. This strain can lead to kidney damage and even kidney failure. It can create numerous other medical problems, including lactic acidosis.

2.3. Lactic acidosis

Kidney damage from prolonged use of Truvada can lead to lactic acidosis. This is the accumulation of lactate in the bloodstream. Without the kidneys working at full function, they fail to remove enough lactate acid from the blood. This leads to the following symptoms:

  • Weakness,
  • Nausea,
  • Vomiting, and
  • Difficulties breathing.
attorneys busy at work
Numerous lawsuits have been filed against Gilead Sciences

3. What is the current state of the Truvada litigation?

Numerous lawsuits have been filed against Gilead Sciences, Inc.6 This includes a class action lawsuit representing victims in the state of California.7 These lawsuits include allegations that Gilead Sciences, Inc. had developed a drug that was safer than Truvada. But the company kept it out of production until Truvada's patent was set to expire.

3.1. Failure to warn and Defective design claims

The bulk of these lawsuits deal with the claim that Gilead Sciences, Inc. knew that Truvada carried serious design defects that cause severe side effects. Gilead also failed to warn doctors or patients of those risks.

The lawsuits claim that Gilead knew that the drug TDF was very toxic in the prescribed doses. And the company even sought a safer version of it right after TDF was approved by the FDA in 2001.8 Nevertheless, Gilead continued to tout TDF and Truvada as “risk-free.” This even after the FDA reprimanded them in 2002 and 2003 for false claims that TDF did not put a patient's bone density or kidneys in jeopardy.9 Truvada continued to be marketed as a safe drug. This in spite of a growing body of scientific evidence to the contrary.10

3.2. Claims that Gilead withheld a safer drug

A significant portion of the failure to warn claim in these lawsuits deals with Truvada manufacturer Gilead's concealed development of another drug, tenofovir alafenamide, or TAF.

An alternative to TDF, TAF is more easily absorbed in the body. This makes it more efficacious, even at significantly lower doses. Gilead had been investigating TAF even before Truvada was approved in 2004.11 Those studies revealed not only that TAF was far less toxic. But also that TDF carried a much greater risk profile.12

However, TDF and Truvada had only recently been patented. It still had years of protection against generic brands. TDF was also the dominant drug in HIV treatment. This allowed Gilead to charge extremely high prices per dose.13

Therefore, rather than release the studies that found TAF was a less toxic alternative to TDF, Gilead covered them up.14 In 2004, Gilead even announced that it would stop researching TAF. It then promptly applied for and received seven patents related to TAF in the span of the next several months.15

Finally, in 2010, the patent on TDF and Truvada was running out. Gilead announced the discovery of a new drug that would revolutionize HIV treatment – TAF.16 Gilead began unveiling the results of its studies on TAF, which had been done years earlier, as proof that it was a better drug for HIV treatment. One with fewer risks of bone density problems and kidney damage than TDF.17 Gilead urged patients on TDF medications to switch to newer, TAF-based drugs like:

  • Genvoya,
  • Odefsey, and
  • Descovy.18

The lawsuits allege Gilead delayed introduction of TAF for business reasons. This came at the expense of patients taking TDF-based HIV treatments. For nearly a decade, they were put at severe risk of osteoporosis, bone fractures, kidney damage, renal failure, and potentially fatal lactic acidosis. All because Gilead wanted to pad their bottom line. Profits came before people.

4. What compensation can victims recover?

Victims of Truvada are likely to have suffered injuries and amassed steep medical bills and other losses. A lawsuit against Gilead can recover the compensation for the losses, pain, and suffering that they have sustained through no fault of their own.

These compensatory damages can come in a variety of forms, including:

  • The costs of medical treatment,
  • Lost income,
  • Pain and suffering, and
  • The loss of consortium suffered by a victim's family.

Additionally, lawsuits pending against Gilead for the effects of Truvada have sought punitive damages.19 These damages seek to punish the makers of defectively advertised drugs for their egregious and dangerous conduct.

5. What you can do if you have been hurt?

Are you taking or have you taken a Truvada-based drug? If so, talk with your doctor about diagnostic tests. Kidney disease can be diagnosed by way of blood or urine test, imaging or biopsies. The first step in diagnosing bone loss is a DEXA scan. A DEXA scan is a dual-energy x-ray that measures bone loss.

It is important to diagnose and treat these injuries as early as possible. 

If the tests reveal kidney or bone damage, you may qualify to bring a lawsuit. Contact a lawyer as soon as possible. There is a statute of limitations (deadline) for filing a Truvada lawsuit or claim. In some cases this may be as short as one year from the onset of the injuries. 
 
 

6. Contact our defective drug lawyers

truvada attorneys
Call us at (855) LAW-FIRM

The lawyers at the Shouse Law Office represent people injured by big pharma. Call us at 855-LAWFIRM to schedule a consultation.


Legal References:

  1. FDA Approval Letter for TDF.

  2. FDA Approval Letter for Truvada.

  3. Iwen F Grigsby, Lan Pham, Louis M Mansky, Raj Gopalakrishnan, and Kim C Mansky. “Tenofovir-associated bone density loss,” Therapeutics and Clinical Risk Management 6:41-7 (2010).

  4. Willem D.F. Venter, June Fabian, and Charles Feldman. “An overview of tenofovir and renal disease for the HIV-treating clinician,” South African Journal of HIV Medicine 19(1):817 (2018).

  5. Pablo Rivas, Jorge Polo, Miguel de Górgolas, Manuel L Fernández Guerrero. “Drug points: Fatal lactic acidosis associated with tenofovir,” British Medical Journal 327:711 (2003).

  6. See Lujano v. Gilead Sciences, Inc., No. BC 702302 (Cal. filed May 18, 2018).

  7. Martinez v. Gilead Sciences, Inc., No. BC 705063 (Cal. filed May 8, 2018).

  8. Complaint at 1, Martinez v. Gilead Sciences, Inc., No. BC 705063 (Cal. filed May 8, 2018).

  9. Id. at 2.

  10. Id. at 2-4.

  11. Id. at 3.

  12. Id.

  13. The yearly cost of Truvada was $18,456 (Id. at 5).

  14. Melody Petersen, “Patients sue Gilead, saying drug company intentionally delayed safer HIV medicine,” Los Angeles Times (May 9, 2018).

  15. See Id. and Complaint at 4.

  16. Petersen, supra note 14.

  17. Id.

  18. Id.

  19. Complaint at 17, Lujano v. Gilead Sciences, Inc., No. BC 702302 (Cal. filed May 18, 2018).

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